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DIN EN ISO 15378:2016-11

Отменен
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to Good Manufacturing Practice (GMP) (ISO/DIS 15378:2016); German and English version prEN ISO 15378:2016 — 85 стр.
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Ссылочные документы

BS ISO/IEC 90003:2004
Заменен
Software engineering. Guidelines for the application of ISO 9001:2000 to computer software — 64 стр.
ISO/IEC 31010:2009
Действует
Risk management -- Risk assessment techniques — 192 стр.
DIN ISO 31000:2011-01
Отменен
Risk management - Principles and guidelines (ISO 31000:2009)
DIN EN ISO 19011:2017-09
Отменен
Guidelines for auditing management systems (ISO/DIS 19011:2017); German and English version prEN ISO 19011:2017
DIN EN ISO 14644-3:2017-02
Отменен
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO/DIS 14644-3:2016); German and English version prEN ISO 14644-3:2016
DIN EN ISO 14644-2:2016-05
Действует
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015) — 22 стр.
ÖNORM EN ISO 14644-15:2018-04
Действует
Cleanrooms and associated controlled environments - Part 15: Assessment of suitability for use of equipment and materials by airborne chemical concentration (ISO 14644-15:2017)
DIN EN ISO 14001 Berichtigung 1:2016-03
Действует
Environmental management systems - Requirements with guidance for use, Corrigendum to DIN EN ISO 14001:2015-11 — 2 стр.
ÖVE/ÖNORM EN ISO 13485:2017-08
Действует
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) (consolidated version)
DIN EN ISO 11137-1/A2:2017-10
Проект
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/DAM 2:2017); German and English version prEN ISO 11137-1:2015/prA2:2017
DIN EN ISO 11135/A1:2017-09
Отменен
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014/DAM 1:2017); German and English version EN ISO 11135:2014/prA1:2017
DIN EN ISO 9004:2017-06
Отменен
Quality management - Quality of an organization - Guidance to achieve sustained success (ISO/DIS 9004:2017); German and English version prEN ISO 9004:2017
DIN EN ISO 9000:2015-11
Действует
Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 — 104 стр.
ISO/IEC Guide 99:2007
Действует
International vocabulary of metrology -- Basic and general concepts and associated terms (VIM) — 108 стр.
ISO Guide 73:2009
Действует
Risk management -- Vocabulary — 24 стр.
ISO/IEC Guide 23:1982
Действует
Methods of indicating conformity with standards for third-party certification systems — 7 стр.
BS IEC 61882:2001
Заменен
Hazard and operability studies (HAZOP studies). Application guide — 60 стр.
DIN IEC 61025:1993-12
Отменен
Fault tree analysis (FTA); identical with IEC 61025:1990
IEC 60812:2006 ed2.0
Заменен
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) — 46 стр.
IEC 60601-1:2005/COR1:2012+AMD1:2012 CSV ed3.1
Действует
Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance — 0 стр.
ASTM E2500-07
Заменен
Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment — 5 стр.
DIN ISO 10007:2004-12
Заменен
Quality management systems - Guidelines for configuration management (ISO 10007:2003) — 16 стр.
DIN EN ISO 19011:2011-12
Отменен
Guidelines for auditing management systems (ISO 19011:2011); German and English version EN ISO 19011:2011
DIN EN ISO 14971:2013-04
Отменен
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012 — 112 стр.
DIN EN ISO 14937:2010-03
Действует
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) — 54 стр.
DIN EN ISO 14698-2:2004-02
Отменен
Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data (ISO 14698-2:2003); German version EN ISO 14698-2:2003 — 15 стр.
DIN EN ISO 14698-1:2004-04
Отменен
Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods (ISO 14698-1:2003); German version EN ISO 14698-1:2003 — 38 стр.
DIN EN ISO 14644-8:2013-06
Отменен
Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC) (ISO 14644-8:2013); German version EN ISO 14644-8:2013 — 28 стр.
DIN EN ISO 14644-7:2005-01
Действует
Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004); German version EN ISO 14644-7:2004 — 60 стр.
DIN EN ISO 14644-5:2005-03
Действует
Cleanrooms and associated controlled environments - Part 5: Operations (ISO 14644-5:2004); German version EN ISO 14644-5:2004 — 52 стр.
DIN EN ISO 14644-4:2003-06
Действует
Cleanrooms and associated controlled environments - Part 4: Design, construction and start up (ISO 14644-4:2001); German version EN ISO 14644-4:2001 — 55 стр.
DIN EN ISO 14644-3:2006-03
Отменен
Cleanrooms and associated controlled environments - Part 3: Test methods (ISO 14644-3:2005); German version EN ISO 14644-3:2005 — 72 стр.
DIN EN ISO 14644-2:2001-02
Отменен
Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 (ISO 14644-2:2000); German version EN ISO 14644-2:2000 — 9 стр.
DIN EN ISO 14644-1:1999-07
Отменен
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness (ISO 14644-1:1999); German version EN ISO 14644-1:1999 — 17 стр.
DIN EN ISO 14001:2015-11
Действует
Environmental management systems - Requirements with guidance for use (ISO 14001:2015); German and English version EN ISO 14001:2015 — 81 стр.
DIN EN ISO 13485:2012-11
Отменен
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012 — 86 стр.
DIN EN ISO 11137-2:2015-11
Действует
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015 — 92 стр.
DIN EN ISO 11137-1:2015-11
Отменен
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) — 54 стр.
DIN EN ISO 11135:2014-10
Отменен
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) — 98 стр.
DIN EN ISO 10012:2004-03
Действует
Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003 — 56 стр.
DIN EN ISO 9004:2009-12
Отменен
Managing for the sustained success of an organization - A quality management approach (ISO 9004:2009); Trilingual version EN ISO 9004:2009 — 140 стр.
DIN EN ISO 9001:2015-11
Действует
Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 — 71 стр.
DIN EN 61025:2007-08
Действует
Fault tree analysis (FTA) (IEC 61025:2006); German version EN 61025:2007 — 50 стр.
DIN EN 60812:2006-11
Действует
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) (IEC 60812:2006); German version EN 60812:2006 — 48 стр.
DIN EN 60601-1-3:1995-02
Отменен
Medical electrical equipment - Part 1: General requirements for safety; 3. collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:1994); German version EN 60601-1-3:1994 — 31 стр.
DIN EN 45020:2007-03
Действует
Standardization and related activities - General vocabulary (ISO/IEC Guide 2:2004); Trilingual version EN 45020:2006 — 74 стр.
DIN EN ISO 15378:2012-02
Отменен
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011); German version EN ISO 15378:2011 — 80 стр.
DIN EN ISO 15378:2014-04
Отменен
Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO/DIS 15378:2014); German version prEN ISO 15378:2014

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